National Vaccine Injury Compensation Program (VICP)

About the Omnibus Autism Proceeding

What is the Proceeding

Beginning in 2001, parents began filing petitions for compensation with the Secretary of Health and Human Services (HHS) under the Vaccine Injury Compensation Program (VICP or Program), alleging that certain childhood vaccinations might be causing or contributing to a neurodevelopmental disorder known as “autism spectrum disorder (ASD),” or “autism” for short.

Specifically, it has been alleged that cases of autism, or neurodevelopmental disorders similar to autism, may be caused by

• Measles-Mumps-Rubella (MMR) vaccinations;
• by the “thimerosal” ingredient previously contained in certain other vaccines; or
• by some combination of these two alleged effects.

The Office of Special Masters (OSM) held a series of meetings in mid-2002 with an informal advisory committee to address the task of dealing with these claims.

The OSM issued Autism General Order #1 in July 2002, in which it established the procedure for addressing the Omnibus Autism Proceeding (OAP). Petitioners' attorneys then initiated an extensive discovery process, a phase which is now concluded.

What Has Happened So Far

To date, the Secretary has produced over 218,000 pages of discovery, and has offered several officials for depositions.

As of February 1, 2009,

• over 5,500 cases alleging a causal relationship between such vaccinations and autism disorders have been filed in the Program;
• 5,152 cases await adjudication. Some petitioners have withdrawn, as is their statutory right, and may be pursuing claims against vaccine manufacturers in civil court, and some have been dismissed because they were filed after the statute of limitations had expired.

2007 Test Cases: MMR and Thimerosal-Containing Vaccines (Theory 1)

The first evidentiary hearing for a test case was held in June 2007. The Petitioners' Steering Committee (PSC) and the Secretary presented expert testimony concerning the “general causation issue” for the combined theory (both MMR vaccine and thimerosal-containing vaccines caused autism), and also the specific causation issue in the first of three test cases for the combined theory.

Hearings in the other two test cases for the combined theory were held in October and November of 2007. The special master's decisions in the first theory and three test cases were released by the Court on February 12, 2009, and can be accessed at Omnibus Autism Proceeding, U.S. Court of Federal Claims, Autism Decisions and Background Information.

2008 Test Cases: Thimerosol-Containing Vaccines (Theory 2)

In May 2008, the Court heard testimony on the general causation issues for the theory that thimerosal causes autism or ASD. Evidence in two test cases was also presented. A third test case, and additional evidence on general causation for the thimerosal theory, was presented during the third week of July. Final decisions on general causation and the three test cases are not expected until later in 2009.

Theory 3 Hearing

A general causation hearing for the third theory (i.e., MMR vaccine alone causes autism or ASD), originally scheduled for September 2008, has been cancelled. In August, petitioners indicated in a letter to the Court that they did not plan to introduce new evidence, and would rely on the MMR vaccine evidence presented in the Theory 1 proceedings. Both sides agreed there was no need for test cases or a general causation hearing.

This information reflects the current thinking of the United States Department of Health and Human Services on the topics addressed. This information is not legal advice and does not create or confer any rights for or on any person and does not operate to bind the Department or the public. The ultimate decision about the scope of the statutes authorizing the VICP is within the authority of the United States Court of Federal Claims, which is responsible for resolving claims for compensation under the VICP.